Peyronie's disease is characterized by a condition of unknown etiology wherein there is the development of plaques or masses of dense fibrous tissue in the fascia about the corpus cavernosum of the penis, resulting in deformation of the penis.
While recent advances have been made in the surgical treatment of Peyronie's disease, specific therapy for the problem continues to be unsatisfactory. It is universally acknowledged that there is no medical or local therapy that provides predictable and lasting benefits for the patient with this distressing problem.
According to the present invention, it has been found that collagenase can be injected into the plaque resulting in the softening with subsequent restoration of penile symmetry and function.
The specific collagenolytic properties of clostridial filtrates were first described in the 1940's. In 1964 it was found to consist of two distinct collagenases. These enzymes have been named Clostridiopeptidase A and Collagenase 2. Purified clostridial collagenase is available commercially in two forms, Worthington Biochemical, Freehold, N.J. 07728, a chromatographically purified preparation containing both collagenases with trace amounts of an unidentified protease contaminant, and a lyophylized chromatographically purified preparation of Clostridiopeptidase A. The bacterial collagenases act at many sites along the peptide chain, clipping short segments from each end. It is active over a wide pH range with an optimum around 7.4. Native collagen is its only substrate; globular, soluble, and other structural proteins are unaffected. Ensyme activity is high at 37.degree. C. It is not subject to autodigestion and is not inhibited significantly in vivo. The purified preparation is quite stable with respect to time and its cost is reasonable. In experimental animals, toxic doses are far in excess of effective therapeutic doses.
The clinical use of bacterial collagenase has heretofore been limited to topical application for debridement of dermal ulcers and burn eschar. It has been proposed for use in treating prolapsed intervertebral discs, as a biochemical curretage of the herniated nucleosus pulposus. Although several animal studies have demonstrated some effect, it has not been used for this purpose in humans to date.
It is believed that the use of collogenase in the treatment of Peyronie's disease represents a significant advance in the art.